A group of researchers, including some from Baylor College of Medicine, reviewed more than 27,000 patients’ outcomes after being treated with this drug, providing additional supportive and valuable safety data on major bleeding and related outcomes in routine clinical practice.
The findings appear in Clinical Cardiology.
Non-valvular atrial fibrillation is the most common cardiac arrhythmia. It can cause heart failure, stroke, poor mental health, reduced quality of life and death.
“Non-valvular atrial fibrillation can have severe outcomes, and the limited treatments we had contain their own set of side effects that can also be deadly,” said Dr. W. Frank Peacock, professor of emergency medicine and research director at Ben Taub Hospital. “We were basically trading a probable outcome of stroke or death for a less certain outcome of death due to internal bleeding. The newer drugs we are using to treat this disorder have been shown to be safer, but still have similar side effects albeit at lower rates, so we need to keep evaluating to find the most effective use.”
Peacock and his colleagues reviewed 27,467 patient records from the U.S. Department of Defense who had received rivaroxaban. They found that less 2 percent of people experienced major bleeding events with the majority of those being gastrointestinal and not the more serious intracranial type. Out of those who did suffer major bleeding, less than 3 percent ended in death. With past treatments such as warfarin, much higher numbers of patients would have suffered intracranial bleeding with a higher chance of dying.
“Overall, there was a low rate of bleeding events The majority of bleeding events were gastrointestinal, which is less deadly than intracranial bleeding, therefore the mortality rate was low,” Peacock said.
Peacock added that with past drugs there were also lifestyle restrictions that are not needed when taking rivaroxaban.
“Patients couldn’t eat certain foods such as spinach. While these restrictions might not seem dramatic, making sure our patients have a good quality of life is very important to overall wellbeing and health.”
Peacock added that these results were consistent with past studies but continued review of patient outcomes helps doctors weigh the benefits of certain types of treatments, learn who is most at risk for side effects, and allows them to educate the patient on all options.
Others who took part in the study include: Dr. Sally Tamayo, Naval Medical Center, Portsmouth, Virginia; Dr. Manesh Patel, Duke University Health System and Duke Clinical Research Institute, Durham, North Carolina; Nicholas Sicignano and Kathleen P. Hopf, Clinical Epidemiology, Health ResearchTx, Trevose, Pennsylvania; Dr. Larry Fields and Dr. Daniel Yannicelli, Janssen Scientific Affairs, LLC, Raritan, New Jersey; Dr.Troy Sarich, Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr. Shujian Wu, Janssen Research and Development, LLC, Raritan, New Jersey; and Dr. Zhong Yuan, Janssen Research and Development, LLC, Titusville, New Jersey.